DHSC to review clinical risk standards for digital health tech

The Department of Health and Social Care will launch a consultation on the clinical risk standards for the use of digital health technologies in 2024/2025, the minister for patient safety has confirmed.

In a letter to Patient Safety Learning, Baroness Gillian Merron said there will be a review of standards DCB0129 and DCB0160, which provide guidelines to help healthcare providers manage and mitigate risks associated with healthcare IT systems.

She wrote to the charity in response its report, ‘Electronic patient record systems: Putting patient safety at the heart of implementation’, published on 31 July 2024, which sets out “significant patient safety risks” relating to EPR rollouts in the NHS.

Its publication followed a BBC investigation, reported in May 2024, which identified 126 instances of serious harm linked to IT issues across 31 acute trusts, including three deaths related to EPR problems.

In a letter dated 17 September 2024, seen by Digital Health News, Baroness Merron said that clinical risk standards play a “crucial role” in patient safety when using EPRs.

“The standards, published in 2012, require organisations to ensure that clinical risk management is embedded in the deployment of EPRs and throughout the life cycle of the technology, including version upgrades.

“NHS England is responsible for ensuring the continued effectiveness of the clinical risk standards.

“A comprehensive review of both standards is planned for 2024/2025, which will involve a public consultation and wide stakeholder engagement,” Baroness Merron said.

She added that NHSE is reviewing digital clinical safety training to help increase accessibility and the number of clinical safety officers (CSOs) across healthcare organisation providers to “support safe implementation and ongoing monitoring of safety risks associated with digital systems”.

Helen Hughes, chief executive of Patient Safety Learning, welcomed the forthcoming consultation, adding that it is “vital” that patient safety is at the core of EPR implementation.

“We welcome proposed steps by NHSE to undertake further analysis aimed at identifying new and under-recognised patient safety issues relating to EPR systems.

“Patient Safety Learning believes there must be transparency in reporting of unintended harm and that such insights lead to learning from EPR implementations, with action taken to directly support front line clinicians in their work and the delivery of safe care.

“It is also important that there are robust safety standards in digital health to keep apace with new technologies as they evolve.

“These standards should be accompanied by strong quality assurance and accountability mechanisms with patient safety at their core,” Hughes said.

Meanwhile, Digital Health Networks launched a CSO Council in July 2024, chaired by Ben Jeeves, associate chief clinical information officer and CSO at Midlands Partnership NHS Foundation Trust.

The council is intended to serve as a platform for collaboration on digital clinical safety and provide CSOs with a space to share knowledge, experience, and best practices.

Digital Health News contacted DHSC and NHSE for comment but had not received a response at the time of publication.